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CREATION AND IMPLANTATION OF AN ARTIFICIAL NAIL FOR THE TREATMENT OF
DEFORMED OR MISSING NAILS

Abstract

The creation and implantation of an artificial nail in the treatment of
deformed or missing nails includes preparing the nail bed. A
polypropylene mesh is applied and anchored to the nail bed. KeryFlex is
applied to the polypropylene mesh.

Inventors:

Bauman; Mark; (Marlton, NJ); Nolan; James; (Branford, CT)

Serial No.:

049961

Series Code:

13

Filed:

March 17, 2011

Current U.S. Class:

128/898

Class at Publication:

128/898

International Class:

A61B 17/00 20060101 A61B017/00

Claims

1. A method of creating and implanting an artificial nail in the
treatment of deformed or missing nails comprising preparing a nail bed,
applying a polypropylene mesh and applying KeryFlex to the mesh.

Description

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application is based upon provisional application Ser. No.
61/315,182 filed Mar. 18, 2010, all of the details of which are
incorporated herein by reference thereto.

BACKGROUND OF INVENTION

[0002] The present invention relates to the creation of artificial nails.
Various techniques have been used in the past to create artificial nails.
These techniques have had differing degrees of effectiveness.

SUMMARY OF THE INVENTION

[0003] An object of this invention is to provide techniques for the
creation and implantation of an artificial nail for the treatment of
deformed or missing nails.

THE DRAWINGS

[0004] FIGS. 1-2 illustrate steps in the preparation of a nail bed in
accordance with this invention;

[0007] FIGS. 10-14 illustrate the steps involved in the creation and
implantation of an artificial nail in accordance with this invention.

DETAILED DESCRIPTION

[0008] The present invention is directed to the creation of artificial
nails. It is to be understood that the practice of this invention may be
accomplished for either toenails or fingernails.

[0009] In general, the invention may be practiced by utilizing an
established technique nail matricectomy which is performed by a chosen
method on the patient's toe or finger while an appropriate tourniquet has
already been placed around the digit, and the digit has been anesthetized
. While the nail bed and matrix are excised sharply (See FIG. 1), leaving
the most distal aspect of nail bed intact, the medial and lateral nail
folds and eponychium are also incised sharply to create a U-shaped
channel, with the open end of the "U" facing distally. See FIG. 2.

[0010] An appropriate-sized sterilized polypropylene mesh is selected. The
mesh is carefully placed onto the digit and the medial and lateral wings
are carefully placed under the medial and lateral nail folds, while the
proximal anchor points are carefully placed under the exposed eponychium.

[0011] The eponychial area may be sutured at the discretion of the
surgeon. At the level of the hyponychium, a continuous suture of a small
gauge is placed between the mesh and most distal nail bed to create a
distal anchorage of the mesh.

[0012] A non-adherent bandage is placed over the wound, and a compression
bandage is placed over this bandage, while the tourniquet is released.
The post-operative course is examined by the surgeon during the
subsequent two weeks.

[0013] The artificial nail (18) works by allowing tissue ingrowth to
occur. When the individual's digital nail is removed, collagen bonds are
broken, causing bleeding and a wound. The healing mechanism for all
wounds causes various chemicals to be released in an attempt to heal the
wound. Ultimately a scab is formed. By placing the polypropylene mesh
about the nail folds and eponychium, as well as at the hyponychium, a
scaffolding mechanism will take place within the healing wound, "locking"
the mesh to the surrounding tissues.

[0014] In instances where there is no existing nail, the cornified nail
bed is removed (again leaving the most distal nail bed intact), causing
the same type of wound and healing mechanism to occur.

[0015] The mesh is of optimal pore size to allow for ingrowth.
Polypropylene is a preferred mesh material because it also has strong
tear resistance, as well as being minimally reactive, so that little to
no foreign body reaction should take place, eliminating the likelihood of
rejection of the mesh.

[0016] When the matrix (i.e. the center growth or tissue of the nail) is
either destroyed (via chemical, laser, etc.) or excised (such as in the
preparation step of FIG. 1), the ability of the nail to continue to grow
or regenerate is severely (if not completely) compromised. Therefore,
with perfect matrix removal or destruction, no new nail forms, and the
tissue which used to be nail, and which would have regenerated nail
tissue, becomes cornified or as thicker skin tissue. This tissue becomes
the platform on which KeryFlex can be applied, with the polypropylene
mesh, with optimal porosity, acting as a perfect interface. Polypropylene
mesh is applied and anchored to the nail bed (by preparing a large
channel in the medial and lateral nail folds and eponychium, and in the
hyponychium, where it is sutured with simple interrupted sutures)

[0017] KeryFlex is a nail restoration system, somewhat similar to a dental
bond, whereby a bonding solution is applied (in this case) to the mesh,
then the gel component is applied to the mesh, then the gel is cured via
ultraviolet light, then more gel might be applied, then cured, then the
sealant is applied, and then cured via ultraviolet light. This cured
"nail" may then be gently shaped via emory board or drill. KeryFlex is
currently used to fill in in poorly shaped or constituted nails by first
applying the bonding solution to the existing nail, and then following
the subsequent steps. KeryFlex cannot bond to a non-active or cornified
nail bed; therefore, the mesh is implanted to act as a scaffold to allow
KeryFlex to bond- or actually surround the mesh.

[0018] The procedure involves removal or destruction of the nail and nail
matrix; when that is accomplished, the polypropylene mesh is implanted;
when wound is stable (no drainage), KeryFlex is applied to the mesh that
has been implanted to the digit.

[0019] At approximately two weeks, by which time the wound should have
fully healed, the KeryFlex treatment should be ready for implementation.
The nail bed will be prepared with an application of the bonding agent
and allowed to dry for two minutes. See FIG. 10.

[0020] When the surface is dry, the chosen shade (clear, natural, or
opaque) of resin material is carefully applied to the meshwork on the
nail bed. This is gently sculpted to create a layer of "nail". Care is
taken to not allow the resin to fall onto tissue where there is no mesh.
See FIG. 11.

[0021] When the mesh is covered with resin to a reasonable depth and
breadth, the resin is exposed to light from ultraviolet lamp for two
minutes, causing the resin to polymerize and harden. See FIG. 12.

[0022] The practitioner determines if a second layer of resin is needed to
create a thicker or fuller nail. If so, the same protocol is utilized as
was done in the previous step, again taking care to not allow the resin
to fall onto non-mesh tissue, and utilizing the ultraviolet lamp. The
nail can then be "formed", as necessary, using either a soft file or
drill bur.

[0023] If the surgeon judges the new nail to be sufficient, corresponding
to an acceptable level relative to the end of the toe, the sealing agent
is then applied (see FIG. 13) and cured for two minutes with ultraviolet
lamp. See FIG. 14.

[0024] Upon completion of this step, additional fine remodeling can be
performed. Nail polish, at the discretion of the patient, can be applied
almost immediately.

[0025] The materials of which the artificial nail is comprised are all FDA
approved and have been used in the United States and other countries for
some time. Medical grade polypropylene is used in, among other areas,
hernia repair, vascular surgery, etc.

[0026] Only a known allergy to polypropylene, the chemicals which comprise
KeryFlex, an open digital growth center, or any condition which would
contraindicate the permanent removal of a digital nail and/or matrix
would otherwise disqualify one's ability to undergo this procedure and
treatment.

[0027] In the kit is the actual replacement polypropylene mesh. See FIG,
3.

[0028] FIG. 5 illustrates an artificial nail which is constructed as a
layer of the resin material on the top of the collagen mesh on the
underside as a cohering layer 24. See FIG. 4 for side view. This collagen
mesh 24 extends distally to approximately 0.5 cm to the free edge 23 of
the nail (and can be made longer, if desired, for toenails and custom
shaped and sized fingernails).

[0029] As the nail 18 is attached to the nail bed B by cohesion, the bond
is permanent and thus is stronger and more mechanically sound than simple
adhesion. The three anchor points 20 on the proximal edge take up most of
the mechanical stress which mimics a natural nail. The bonding which
occurs peripherally is similar to what is found naturally that being the
microadhesions which secure the nail plate to the underlying nail bed.
Fibroblasts are generated from the created wound and should migrate along
the collagen fibers which are adhered to the roughened, mesh-configured
surface porous implant. Resin is chosen as the artificial nail material
due to its inherent strength, history of biocompatibility, its ability to
withstand erosion and abrasion, and its ability to be colored either
industrially (to create the original color) or by items such as nail
polish.

[0030] The procedure itself has no untoward effects, save the possible
sensitivity one may have to the material (but the lack of a nail often
creates a greater sensitivity which is quite evident post-operatively
with patients who learn to accept it). If the nail 18 would need to be
removed, an additional surgical intervention would be required. In the
case of injury to the toe where the nail implant was partially destroyed
or damaged, a replacement nail could be reapplied in the same fashion as
the original implant surgery. The procedure affords the patient cosmetic
relief for a perceived unsightly condition and enhances both beauty and
self-assuredness and a general feeling of comfort in society. The
invention provides a more permanent and acceptable alternative to the
current status quo; it also increases by its very design and application,
a higher level of acceptance on the part of the general population and
affords a cosmetic as well as functional (as relates to sensation)
correction of those who desire.